Clinical trial · Interventional
ATAC - Pharmacokinetics (PK) Sub-Protocol
A Randomised, Double Blind Trial to Assess the Pharmacokinetics of Arimidex Alone, Nolvadex Alone, or Arimidex and Nolvadex in Combination, When Used as Adjuvant Treatment for Breast Cancer in Postmenopausal Women
NCT00784862CI-TRIAL-00002310completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To assess the effect of ARIMIDEX on the pharmacokinetics of tamoxifen and the effects of tamoxifen on the pharmacokinetics of ARIMIDEX..
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anastrozole | Drug | Anastrozole | ALIAS |
| Tamoxifen | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Arimidex 1mg + Nolvadex placebo
- interventionNames
- Drug: Anastrozole
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- Arimidex placebo + Nolvadex 20mg
- interventionNames
- Drug: Anastrozole
- Drug: Tamoxifen
- type
- ACTIVE_COMPARATOR
- label
- 3
- description
- Arimidex 1mg + Nolvadex 20mg
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Eligible for entry into the main ATAC trial 1033IL/0029 * Patients must have been taking ATAC trial medication for at least 3 months (i.e. patients must have reached at least visit 2 of the main ATAC study) * Patients should be taking their medication in the mornings for at least 3 months * Patients must be 100% compliant over the preceding fourteen days Exclusion Criteria: * Excluded from entry into the main ATAC trial (1033IL/0029) * Patients whose concurrent treatment includes diazepam or drugs which might affect tamoxifen steady state levels or steroid hormone status. These include ketoconazole (antifungal) or related compounds
References
Publications (0)
Data not yet available
No reference posted for this study.